A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)

NCT04945018 · tracked via the Priya Life Science Japan tracker

Sponsor

Heartseed Inc

Phase

Phase 1/2

Started

2022-04-19

Last updated

2025-09-22

Condition(s) studied

Heart FailureIschemic Heart Disease

Investigational drug(s) / intervention(s)

HS-001 CSHS-001-D needle, HS-001-D Adaptor

HS-001 CS: Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension

HS-001-D needle, HS-001-D Adaptor: Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors

Study summary

The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.

Eligibility

Sex

ALL

Min age

20 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on either screening cardiac MRI or echocardiographic assessment * New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening * Other Criteria apply, please contact the investigator Exclusion Criteria: * Patients screened less than 1 month after the onset of myocardial infarction * Patients with congenital heart disease, or cardiac sarcoidosis * Other Criteria apply, please contact the investigator

Primary outcome measure(s)

Safety and Tolerability — 26 weeks post-transplant
Adverse events and safety in the 26 weeks after HS-001 CS transplantation

Trial sites (8)

Facility	City	Region
St. Marianna University Hospital	Kawasaki	Japan
Saitama Medical University International Medical Center	Saitama	Japan
Juntendo University Hospital	Tokyo	Japan
Nihon University Itabashi Hospital	Tokyo	Japan
The University of Tokyo Hospital	Tokyo	Japan
Tokyo Medical and Dental University Medical Hospital	Tokyo	Japan
Tokyo Metropolitan Geriatric Medical Center	Tokyo	Japan
Tokyo Women's Medical University	Tokyo	Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04945018 on ClinicalTrials.gov ↗ ← All trials in Japan